Navigation Links
The FDA Issues Class 1 Recall for Stryker’s Oasys Midline Occiput Plate Due to a Key Defect, Reports Parker Waichman LLP

New York, New York (PRWEB) September 04, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that the U.S. Food and Drug Administration (FDA) posted an Aug. 29 safety alert to inform the public of a class 1 recall of Stryker’s Oasys Midline Occiput Plate, which is used in cervical spinal fusion surgery, based on reports that, following surgery, the pin that connects the tulip head to the plate body can break. Such a fracture could lead to destabilization of the plate, and revision surgery may be required, the FDA warned in the safety alert.

For those implanted with this device, there is the possibility of serious adverse health consequences, including blood loss and nerve injury, as well as revision surgery to replace the fractured implant, noted the FDA’s safety alert.

Class I recalls are the most serious – involving situations “in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA reported in the safety alert. If a patient begins suffering from symptoms such as pain, weakness, or numbness, “urgent evaluation is needed,” the FDA said in the safety alert, adding that “for patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.”

“We hope that anyone who has had cervical spinal fusion surgery involving the implanting of Stryker’s Oasys Midline Occiput Plate becomes aware of this safety alert and takes it seriously,” said Parker Waichman LLP, a national law firm that actively investigates cases involving injuries caused by defective drugs or medical devices.

In the FDA’s initial recall announcement of the product, issued on May 30, 2013, it noted that the Oasys Midline Occiput Plate is part of the Oasys System, which is used in spinal surgery to promote fusion and provide stabilization at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine.

On July 22, the Australian Government’s Department of Health and Ageing issued a hazard alert regarding the Oasys Midline Occipital Plate.

Parker Waichman LLP continues to offer free legal consultations to victims of injuries caused by defective medical devices. If you or a loved one experience an injury or health problem associated with a defective medical device, please contact their office by visiting the firm's Defective Medical Devices page at Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1-(800) LAW-INFO
1-(800) 529-4636

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. UCSF chancellor issues call-to-arms to patient advocates
2. Radiologists rank themselves as less than competent on health policy issues
3. Genetic abnormalities in benign or malignant tissues predict relapse of prostate cancer
4. FDA Issues Multiple Sclerosis Drug Alert
5. Quality of care, other issues may cause worse results in black prostate cancer surgery patients
6. U.S. Task Force Issues Blood Pressure Guidelines
7. Internists in Washington to discuss patient and professional issues in meetings on Capitol Hill
8. Cheaper drug could lead to serious eye issues
9. Insulite Labs announces the launch of the PCOS Inspiration Hour, a one hour virtual gathering place for women with PCOS and other women’s health issues to come together.
10. Issues Report on Prostate Health Claim Lawsuits and Propecia Side Effect Litigation
11. What Men Should Know About Veins: Varicose Veins and Venous Disease are Real Medical Issues
Post Your Comments:
(Date:12/1/2015)... ... December 01, 2015 , ... On Tuesday 27 Oct ... to educate the personnel on spinal decompression therapy and offer his professional help. ... procedure. The benefits come from creating negative intradiscal pressure which is conducive to ...
(Date:12/1/2015)... ... December 01, 2015 , ... The Multiple System Atrophy Coalition has announced the ... System Atrophy (MSA) research, timed today to coincide with Giving Tuesday 2015, a global ... their ability to work and be productive, to do simple daily activities like walking ...
(Date:12/1/2015)... ... December 01, 2015 , ... The North American Meat ... that meat and poultry play in a healthy, balanced diet. , includes ... visitors can check their “meat IQ,” a section offering straight talk on controversies, ...
(Date:12/1/2015)... ... December 01, 2015 , ... World Patent Marketing , a vertically ... patent that allows for easier packing and organizing of items into one big, portable ... says Scott Cooper, CEO and Creative Director of World Patent Marketing and Desa ...
(Date:12/1/2015)... ... December 01, 2015 , ... Henderson, a town of about ... Internet through a partnership this year with Aeneas Internet and Telephone. , With ... destination for entrepreneurs who want to build a business. Whether startups or long ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... -- A large study of patients with breast cancer who ... found no increased risk of recurrence. The Kaiser Permanente ... National Cancer Institute. --> ... drug taken by women with breast cancer to reduce ... for five years, but has notable side effects, including ...
(Date:12/1/2015)... BOTHELL Wash. and VANCOUVER ... Monitoring Committee (DMC) meeting, OncoGenex Pharmaceuticals, Inc. (NASDAQ: ... trial is continuing based on the pre-planned interim futility ... safety review, no new safety issues were identified by ... to all analyses and final results are expected in ...
(Date:12/1/2015)... HERNDON, Va. , Dec. 1, 2015 ... (FDA) Drug Supply Chain Security Act (DSCSA) approaches, ... helping small and independent pharmacies comply with looming ... --> InfiniTrak is entering endorsement agreements with ... a pharmacy services administration organization (PSAO) to exclusively ...
Breaking Medicine Technology: